The Protocol Review and Monitoring System (PRMS) at M. D. Anderson is designed and operated to ensure that the clinical research performed is of the highest quality possible. The primary elements of the PRMS are: the scientific review process by either the Clinical Research Committee (CRC) for treatment protocols or the Psychosocial, Behavioral, and Health Services Research Committee for quality-of-life and prevention studies; the Protocol Data Management System (PDMS) which is the centralized clinical trial database used for protocol activation and termination and patient registration with eligibility checklists; and twice yearly electronic accrual audits by the Quality Assurance Group to monitor the progress of each clinical trial. During the last grant period, an electronic system has been developed and implemented that allows principal investigators (PIs) to develop and submit their protocols to the scientific review committees electronically through the same system the institution uses for email. The protocols are then electronically forwarded to the reviewers, and the entire dialogue between the reviewers and the PI is on-line. This new system, the Protocol Document On-Line System (PDOL) eliminates a tremendous amount of paper and speeds up the process with enhanced accuracy. PDOL has version control, allows for protocol revisions to be submitted, and keeps all documents associated with a protocol together in a single electronic folder. As a result of the efficiencies gained from PDOL during the last granting period, the protocol review and approval process has been re-engineered so that there are now 2 CRC and 2 IRB meetings per month. This allows PIs to reach the stage of protocol activation within 4 weeks of submission. The increased number of meetings was necessary to accommodate the near 300% increase in the number of protocols submitted for review during the last grant period. Additional staff members have been hired to keep up with increases in volume. The dramatic increase in the cost of running the protocol review and approval process has been paid by the institution and user fees. Currently, the percent of funds provided by the institution, user fees and the CCSG are 55%, 30%, and 15%, respectively. This resource has 278 users, of which 28% have peer-reviewed funding.